Effectiveness of the Functional Hand Splint and Specific Tasks in the Domiciliary Environment Applied to Children With Unilateral Cerebral Palsy

July 16, 2019 updated by: Universidad San Jorge

Effectiveness of the Functional Hand Splint and Specific Tasks in the Domiciliary Environment Applied to Children With Unilateral Cerebral Palsy. Randomized Clinical Trial

The main objective:

To determine the effectiveness of a treatment that combines the application of a functional upper limb orthosis together with a home-based program of specific tasks in children with unilateral cerebral palsy versus a home-based program of specific tasks in improving structure and function, activity and participation.

Hypothesis:

The application of a functional upper limb orthosis together with a home-based program of specific tasks in children with unilateral cerebral palsy results in a greater improvement in structure and function, activity and participation compared to the implementation of a home-based specific task program.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized clinical trial with blinding of the evaluator and the person analyzing the data.

A home-based protocol of specific tasks will be performed in both groups and one of the groups will also receive a treatment with upper limb splinting. The assessment will be made by a single evaluator with 10 years of experience in the treatment of children with motor disabilities.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Zaragoza, Spain, 50830
        • Universidad San Jorge
      • Zaragoza, Spain, 50011
        • AIDIMO Asociación para la investigación en la discapacidad motriz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosis of unilateral cerebral palsy (hemiplegia-hemiparesis).
  2. Ages between 5 and 12 years.
  3. Levels I-III of the Manual Ability Classification System (MACS)
  4. Levels I-III of the Gross Motor Function Classification System (GMFCS)
  5. Able to understand and respond to verbal instructions.

Exclusion Criteria:

  1. Cognitive impairment identified by the school report.
  2. Hand orthopedic surgery in the last 6 months.
  3. Neuropharmacological intervention in the last 6 months.
  4. Allergy to upper limb orthosis material.
  5. Affectation of the manual function not due to the neurological condition (trauma, burn ...).
  6. Current treatments not compatible with the study.
  7. Other significant neurological affections (crisis, severe visual impairment ...).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Upper-limb splint and home-based protocol in specific tasks
Device: Home-based protocol in specific tasks
The home-based protocol in specific tasks will be an individualized protocol designed for the child according to the results of the baseline assessment and will require active participation. It is a program that is integrated into the daily routines of the child. A study investigator will tell the family the procedure to follow.
Device: Upper-limb splint
In the case that treatment with splint is also received, a researcher of this study will take measurements of the hand and will provide the appropriate splint. The intensity of the application will be 5 days a week from monday to friday, for 6 hours a day, for a period of 6 weeks.
Active Comparator: Control group
Home-based protocol in specific tasks
Device: Home-based protocol in specific tasks
The home-based protocol in specific tasks will be an individualized protocol designed for the child according to the results of the baseline assessment and will require active participation. It is a program that is integrated into the daily routines of the child. A study investigator will tell the family the procedure to follow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome_Change from baseline Assisting Hand Assessment measure. Measurement of bimanual performance in pre-established tasks
Time Frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Activity measurement: Assisting Hand Assessment. Measurement of bimanual performance in pre-established tasks. It quantifies the effectiveness with which the child uses his affected hand in bimanual activities.
Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Primary Outcome_2. Change from baseline Children's Hand-use Experience Questionnaire measure. Measurement of bimanual performance in activities of daily living.
Time Frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Participation and activity measurement: Children's Hand-use Experience Questionnaire. The objective of the questionnaire is to measure bimanual performance in activities of daily living.
Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Outcome_Change from baseline Box and Blocks Test measure. Measurement of unilateral gross manual dexterity.
Time Frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Activity measurement: Box and Blocks Test assesses unilateral gross manual dexterity.
Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary Outcome_2. Change from baseline Jebsen Hand Function Test measure. Measurement of a broad range of uni-manual hand functions required for activities of daily living.
Time Frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Participation measurement: Jebsen Hand Function Test. The objective of this test is to assess a broad range of uni-manual hand functions required for activities of daily living.7 activities performed with the affected hand and healthy hand separately.
Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary Outcome_3. Change from baseline House Thumb in Palm Deformity Classification. Classify the deformity level of thumb.
Time Frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Structure and function measurement: House Thumb in Palm Deformity Classification. This tool classify the deformity levels taking into account the structure of the thumb.
Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary Outcome_4. Change from baseline Neurological Hand Deformity Classification. This tool classify the deformity levels of wrist and fingers.
Time Frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Structure and function measurement: Neurological Hand Deformity Classification. This tools classify the deformity levels taking into account the wrist, fingers.
Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary Outcome_5. Change from baseline Grip and Pinch Strength measure. Measurement of pinch, wrist and foream strength.
Time Frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Structure and function measurement: Grip and Pinch Strength. One will be used to Assess the grip of the thumb (Pinch Gauge Dynamometer) and another to assess the strength of the wrist and forearm (Hand and Wrist Dynamometer).
Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad San Jorge

Collaborators

AIDIMO Asociación para la investigación en la discapacidad motriz

Investigators

  • Study Director: María Ortiz Lucas, PhD, Universidad San Jorge
  • Study Director: Vanesa Abuín Porras, PhD, Universidad Europea de Madrid
  • Principal Investigator: Patricia Roldán Pérez, MSc, Universidad San Jorge

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2017

Primary Completion (Actual)

February 28, 2019

Study Completion (Actual)

March 19, 2019

Study Registration Dates

First Submitted

September 6, 2017

First Submitted That Met QC Criteria

September 11, 2017

First Posted (Actual)

September 14, 2017

Study Record Updates

Last Update Posted (Actual)

July 17, 2019

Last Update Submitted That Met QC Criteria

July 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF_TE_01_Versión 3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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